Discontinue promptly if sensitization or irritation
It is recommended that the following precautions be
observed in prescribing and administration of this agent:
- Extreme caution is indicated in patients with
demonstrable dermatologic idiosyncrasies or with history of allergic reactions
- Exposure of the ear canal to the CERUMENEX Eardrops
should be limited to 15-30 minutes.
- When administering CERUMENEX Eardrops, care must be taken
to avoid undue exposure of the skin outside the ear during the instillation and
the flushing out of the medication. If the medication comes in contact with the
skin, the area should be washed with soap and water. Use of proper technique
(see DOSAGE AND ADMINSITRATION) will help avoid such undue exposure.
- CERUMENEX Eardrops should be used only with caution in
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term animal studies have not been performed to
evaluate the carcinogenic potential or the effect on fertility of CERUMENEX
Pregnancy Category C. Animal reproduction studies
have not yet been conducted with CERUMENEX Eardrops. It is also not known
whether CERUMENEX Eardrops can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. CERUMENEX Eardrops should be given
to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when CERUMENEX Eardrops are administered to a nursing mother.
Safety and effectiveness in children have not been
No overall clinical differences in safety or
effectiveness have been observed between the elderly and other adult patients.